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Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS, 60% of Patients Show No

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Feb 19, 2011.

  1. Esther12

    Esther12 Senior Member

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    Just to be clear here... actometer's weren't a part of the Pace protocol. But in the comments section for that paper White says that there was a plan to use actomemters, but that these were droppped because of the inconveniece thaty'd cause patients (?!). So it's a worthile point, but I didn't want people to get it confused with the numerous changes to aspects of Pace which had been officially announced in the protocol.

    The only data on it (I think) is in that comments section: http://www.biomedcentral.com/1471-2377/7/6/comments
  2. Dolphin

    Dolphin Senior Member

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    Yes, that's a good summary, Esther12.
  3. Dolphin

    Dolphin Senior Member

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    It is true and is very unusual from everything I have heard. I don't think the figure was ever calculated. Doing some rough figures it may be in the order of UK150,000 perhaps (i.e. they weren't a big funder). Dr. Mansel Aylward may have helped get them the money - he know works in the UNUMProvident centre in Cardiff.
  4. Dolphin

    Dolphin Senior Member

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    Michelle, you make some good points.

    Here's the press release for what it's worth. It didn't give too many numbers away:
  5. Sean

    Sean Senior Member

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    If the actometers, which are designed to be as unobtrusive and convenient as possible to wear, are too much hassle for patients, then the patients must be pretty physically limited to start with.

    The lack of objective activity measures seriously limits the validity of the already modest results.



    Also found these, not sure if they have been posted here before. Overall they seem to indicate a high validity for actometers as a measure of overall activity, but that pedometers are not so reliable.

    The use of pedometer and actometer in studying daily physical activity in man. Part I: Reliability of pedometer and actometer.
    W. H. M. Saris and R. A. Binkhorst
    EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
    Volume 37, Number 3, 219-228, DOI: 10.1007/BF00421777

    The purpose of this study was a critical evaluation of pedometer and actometer for estimating daily physical activity.
    Both instruments were tested for reliability on a carriage with movements in different directions. To obtain comparable data of different pedometers it was necessary to adjust the spring tension very carefully. The reliability of the individual actometer was satisfactory, but there are large differences between the watches. Therefore, a correction factor (C.F.) was introduced.
    Some experiments were carried out on a treadmill. 9 Children (aged 56 years) and 6 young adult males (aged 2131 years) walked and ran at different speeds. The energy expenditure was calculated from formulas. The pedometer overestimates the actual step rate with 0.10.3 counts per step during fast walking (69 kmh1) and fast running (15 kmh1). It underestimates the actual step rate with 0.20.7 counts per step, while walking slowly. It was shown that the pedometer does not reflect the differences in energy expenditure levels at different speed very well. The actometer units per step increases more or less proportional to the speed of walking and running. In contrast to the pedometer results the actometer results are more related to the energy expediture levels at different speed.
    The results of this study suggest that the actometer might be a valid indicator of the daily physical activity in terms of energy expenditure.



    The use of pedometer and actometer in studying daily physical activity in man. Part II: Validity of pedometer and actometer measuring the daily physical activity.
    Authors: W. H. M. Saris and R. A. Binkhorst
    EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
    Volume 37, Number 3, 229-235, DOI: 10.1007/BF00421778

    The validity of the pedometer and actometer for estimating the daily physical activity was evaluated by means of an observation study. The physical activity in a classroom of 11 pupils of a kindergarten was assessed by means of a pedometer, actometer and by observation. Besides this an activity questionnaire was completed by the infant-quide. On basis of the individual observation it is clear that the infant-guide can give valuable information about the activity of the children at school.
    The results of the pedometer attached to the waist and the actometers attached to the ankle were significantly correlated with the results of the observation method. The wrist actometer showed a smaller but still significant correlation with the other variables. Implications of this findings are discussed in regard toward the physical activity. The pedometer results point out that when the percentage of intense activity is high the pedometer tends to underestimate the level of activity.
    The actometer results indicate that such a motion recorder gives a reliable estimation of activity in children. The findings are discussed in terms of the practical applications of the actometer in the research of daily physical activity and the physical rehabilitation treatment of certain diseases.



    Measuring Activity Level with Actometers: Reliability, Validity, and Arm Length.
    Authors: Eaton, Warren O.
    Child Development, v54 n3 p720-26 Jun 1983

    The gross-motor activity of 27 three- and four- year-olds was assessed through teacher ratings, parent responses to the activity scale of the Colorado Childhood Temperament Inventory, and data from uncalibrated actometers worn by children during free play. Activity scores composited across multiple actometers had high reliability and correlated strongly with the other two measures.


    Correlations of pedometer readings with energy expenditure in workers during free-living daily activities.
    Hiroshi Kashiwazaki, Tsukasa Inaoka, Tsuguyoshi Suzuki and Yasuyuki Kondo
    EUROPEAN JOURNAL OF APPLIED PHYSIOLOGY AND OCCUPATIONAL PHYSIOLOGY
    Volume 54, Number 6, 585-590, DOI: 10.1007/BF00943345

    ... The whole day readings of the pedometer for all the subjects moderately correlated (r=0.438,p<0.05) with the net energy cost (NEC) as determined by subtracting the sleeping metabolic cost from the energy expenditure (clerical workers:r=0.781,p<0.01; assembly workers:r=0.188,p>0.05). The correlation analysis of the pedometer readings with the NEC in three activity phases in a day (work, commuting and staying at home), showed that the extent of the relationship differed by job types and activity phases. The best correlation was obtained during commuting in both of the job types (clerical workers:r=0.843,p<0.01; assembly workers:r=0.743,p<0.01). During work, a quite strong correlation (r=0.889,p<0.01) was obtained with the clerical workers but not with the assembly workers. No significant correlations were found in the data while the subjects were at home. The capacity of the pedometer to detect the impacts of body movements, and the characteristics of activity, are responsible for the differences in correlation. The limitations of the pedometer suggested in the present study must be taken into account if the device is to be used for measuring physical activity. A particular advantage of the device appears in its use for a sedentary population without regular srenuous exercise or static contractions.


    Approaches to estimating physical activity in the community: calorimetric validation of actometers and heart rate monitoring.
    Avons P, Garthwaite P, Davies HL, Murgatroyd PR, James WP.
    Dunn Clinical Nutrition Centre, Cambridge, UK.
    Eur J Clin Nutr. 1988 Mar;42(3):185-96.

    The relationship between actometer measurements, heart rate monitoring and energy expenditure during exercise and resting periods was assessed in a whole-body indirect calorimeter on 12 young male volunteers. Equations derived from these studies were applied to actometer measurements taken during a further 7 d recording in free-living conditions to predict daily energy expenditure over 1 week on an individual basis. Actometers proved to be a satisfactory means of estimating energy expenditure and heart rate monitoring improved the estimates in a few selected subjects. Indirect measures of energy expenditure could be developed by this approach but individual calibration is essential.


    Measuring activity using actometers: A methodological study
    Warren W. Tryon
    JOURNAL OF PSYCHOPATHOLOGY AND BEHAVIORAL ASSESSMENT
    Volume 6, Number 2, 147-153, DOI: 10.1007/BF01350169

    Actometers are men's self-winding mechanical wristwatches that have been modified such that they measure activity rather than time. Actometers can be used to obtain longitudinal naturalistic measures of activity concerning a variety of clinical populations. However, no systematic methodological research has been conducted with regard to the site of attachment and the duration of measurement necessary to ensure valid results. This article presents the results of a methodological study designed to answer these questions. The mean activity levels associated with the Left Wrist and Ankle were nearly equal to those associated with the Right Wrist and Ankle. The Ankle readings were substantially greater than the Wrist readings because the subjects' legs were longer than their arms. The data from Week 2 were the same as those from Week 1.
  6. Sean

    Sean Senior Member

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    The proven false assumption of deconditioning certainly needs challenging.
  7. anciendaze

    anciendaze Senior Member

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    Actually, I'm willing to stipulate that they completely reversed deconditioning -- and obtained only a tiny fraction of the improvement needed to restore health. The false assumption concerns the degree to which the drop in activity in this disease is the result of deconditioning, not the cause.

    My take on the measurements is that all the common gains for different treatment modalities are the result of either a Hawthorne effect or interventions to prevent "adverse outcomes". These should be expected to disappear if treatments are expanded.

    In ordinary practice, doctors are typically unaware of adverse events unless these are forcefully brought to their attention. (Memorable quote during a call from a hospital bed: "YOU HAD A SEIZURE?!!" ) Pushing GET without careful attention to adverse events comparable to that in the study, with appropriate interventions, is a recipe for disaster. This has direct implications for safety, effectiveness and cost.
  8. Bob

    Bob

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    Yes, it certainly does.
    I think that this trial is excellent proof that ME is not caused by, or perpetuated by, either deconditioning or psychological factors.
    If it was then the best CBT and GET available to patients, would have done more than a 10% reduction in fatigue levels.
    But unfortunately it won't be so easy to convince the establishment of that!
  9. Bob

    Bob

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    There are some short video segments, related to the PACE Trial, published on The Lancet online...


    Interview with Professor Trudie Chalder:
    http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962a.html

    Interview with Professor Michael Sharpe:
    http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962b.html

    Lancet TV reports from the press conference in London:
    http://download.thelancet.com/flatc...-up-pages/popup_video_S0140673611600962c.html



    But I don't recommend watching this patronising drivel, unless you want to blow a gasket!
    Not only are they patronising, the videos are also unscientific, factually inaccurate, and completely biased and one-sided.
  10. Dolphin

    Dolphin Senior Member

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    Their step counts should have increased more too. No difference for the CBT group and the GET group going around at a slow rate. One might expect a group who did an exercise program for a year (well 6 months and then they were followed) to have a better than average fitness level, especially when many weren't working (presumably) so would have plenty of time to devote to exercise.
  11. Bob

    Bob

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    Here's Action for ME's response to the trial...
    It's quite an interesting response, seeing as Action for ME helped to set the study up in the first place!

  12. Bob

    Bob

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    Exactly, the study blows all the myths about ME right out of the water... I really hope that we can all make our objections stick, at least a little bit, and make a positive difference from the results of this study... It's going to be a big fight though, isn't it!
  13. anniekim

    anniekim Senior Member

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    Mithriel, you write, 'They selected first using the Oxford Definition but ME patients are actively excluded at that point as they often have neurological signs so they cannot be selected afterwards'.

    Sorry have I been misunderstanding this? I thought the Oxford Criteria meant that neurological symptoms, pem etc.are not required to get a diagnosis of CFS, just fatigue (which could be due to depression, anxiety, burn out and so on these are not exclusions in the Oxford criteria), but neurological symptoms and PEM alongside fatigue does not mean you are excluded from a diagnosis of CFS (in UK often interchanged wih M.E) under the Oxford criteria?

    Would really appreciate an answer to this as Mithriel's assertion that people with the classic symptoms of M.E/CFS such as neurological and post exertional malaise would be excluded from a diagnosis under the Oxford criteria - and if true would not be even studied under the Pace trial - has really confused and thrown me. Many thanks in advance.
  14. Cort

    Cort Phoenix Rising Founder

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    Short and sweet and right to the point! Very nice!
  15. Cort

    Cort Phoenix Rising Founder

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    Absolutely - the program was supposed to start, as I remember with something like 15-30 minute walks four or five times a week...(that's from memory - whatever it was I was surprised at how much walking they were doing)......yet at the end they were still toddling along! They weren't even at a normal walking pace..
  16. anciendaze

    anciendaze Senior Member

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    For 6 minutes! This is like 1/2 a healthy pace for 1/5 of a minimal health walk or 1/10 of a modest exercise walk. Heart attack victims often do better. (Anyone have a handy reference for walking after heart attacks?)
  17. Mog

    Mog

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    At least The Scotsman printed Action for ME's letter, as they hadn't printed any other responses in the actual newspaper to their article so far (link below), although there were a couple of good comments made online. The headline in the newspaper article was "ME can be tackled by counselling and exercise, say scientists" and the article says "Scientists...believe it could herald a new dawn for the treatment of ME". I agree with the grumpy Scotsman's opinion of that ... :headache:

    http://www.scotsman.com/health/ME-sufferers-given-hope-as.6720159.jp
  18. anniekim

    anniekim Senior Member

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    Cort, thanks for this overview, it's really helpful. I read the following in an English newspaper,

    'Overall, 60 per cent of patients who received CBT or GET made progress and 30 per cent recovered sufficiently to resume normal lives'.

    From reading your excellent overview, I don't see how the quote of 30 per cent recovered sufficiently to resume normal lives fits in? Please can you explain? Many thanks.
  19. Esther12

    Esther12 Senior Member

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    The most disturbing thing about the trial is how it has been oversold. "We can cure you... you just need to accept that you'll always be tired!"


    I've just collected together a lot of the analysis of there figures here: http://forums.aboutmecfs.org/showthread.php?4926-PACE-Trial-and-PACE-Trial-Protocol/page24 I still don't really understand how they're counting a SPF score of 60 as normal.

    edited: I'm getting tired and cranky about this.
  20. Dolphin

    Dolphin Senior Member

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    They said this was within 1 S.D. of the norm for the population.
    It isn't for most of the populations I have seen and does not represent being healthy.

    Basically for the following 10 questions, you score 10 points if one says:
    "No, Not Limited At All" to a question and 5 points if one says: "Yes, Limited A Little".

    So one could (say) put "Yes, Limited A Lot" to 2 of the questions and "Yes, Limited A Little" to 4 more and still satisfy their recovery-type definition.

    Also, a lot of the people in the PACE Trial wouldn't be working - some of the people who scored 60+, might not reach the threshold if they were working at the same time.

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